[Federal Register: October 10, 2007 (Volume 72, Number 195)]
[Notices]
[Page 57587-57588]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc07-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0357]
Medical Device User Fee and Modernization Act; Notice to Public
of Web Location of 2008 Proposed Guidance Development; Establishment of
a Public Docket
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the Web
location where it will post a list of guidance documents the Center for
Devices and Radiological Health (CDRH) is considering for development.
In addition, FDA is establishing a docket where stakeholders may
provide comments and/or draft language for those topics as well as
suggestions for new or different guidances.
DATES: Submit written or electronic comments at any time.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Deborah A. Wolf, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 240-276-2350.
SUPPLEMENTARY INFORMATION:
I. Background
During negotiations over the reauthorization of the Medical Device
User Fee and Modernization Act (MDUFMA), FDA agreed, in return for
additional funding from industry, to meet a variety of quantitative and
qualitative goals intended to help get safe and effective medical
devices to market more quickly. These commitments include annually
posting a list of guidance documents that FDA's Center for Devices and
Radiological Health (CDRH) is considering for development and providing
stakeholders an opportunity to provide comments and/or draft language
for those topics, or suggestions for new or different guidances. This
notice announces the Web location of the list of guidances CDRH is
intending to work on over the next fiscal year. We note that the agency
is not required to issue every guidance on the list, nor is it
precluded from issuing guidance documents that are not on the list. The
list includes topics that currently have no guidance associated with
them, topics where updated guidance may be helpful, and topics for
which CDRH has already issued Level 1 drafts that may be finalized
following review of public comments. We will consider stakeholder
comments as we prioritize our guidance efforts.
We also note that CDRH's experience over the years has shown that
there are many reasons CDRH staff cannot complete the entire annual
agenda of guidances it undertakes. Staff are frequently diverted from
guidance development to other activities, including review of premarket
submissions or postmarket problems. In addition, the Center is required
each year to issue a number of guidances it cannot know about in
advance. These may involve newly identified public health issues as
well as special control guidance documents that are necessary for the
classification of de novo devices. It will be helpful, therefore, to
receive comments that indicate the relative priority of different
guidance topics to interested stakeholders.
The Center expects that the recent initiatives it has taken to
streamline and track guidance development will improve its capacity to
issue more guidance documents. The posting and the establishment of a
docket announced through this notice is one of the ways CDRH hopes to
enhance the process. Through feedback from stakeholders, including
draft language for guidance documents, CDRH expects to be able to
better prioritize and more efficiently draft guidances that will be
useful to industry and other stakeholders. FDA intends to update the
list each year.
FDA invites interested persons to submit comments on any or all of
the guidance documents on the list. FDA has established a specific
Docket (see docket number found in brackets in the heading of this
document) where comments about the list, draft language for guidance
documents on those topics, and suggestions for new or different
guidances may be submitted. FDA hopes this docket will become an
important tool for receiving information from interested parties and
for sharing this information with the public.
[[Page 57588]]
Similar information about planned guidance development is included in
the annual agency-wide notice issued by FDA under its good guidance
practices (21 CFR 10.115(f)(5)). This CDRH list, however, will be
focused exclusively on device-related guidances and will be made
available on FDA's Web site prior to the beginning of each fiscal year
from 2008 to 2012.
II. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday. Comments submitted to this docket may include draft
guidance documents that stakeholders have prepared for FDA's
consideration.
To access the list of the guidance documents CDRH is considering
for development in 2008, visit the FDA Web Site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy08.html
.
Dated: October 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-19864 Filed 10-9-07; 8:45 am]
BILLING CODE 4160-01-S